Drug factory · FDA FEI 2435254

Milbar Laboratories, Inc.

20 Commerce Street, East Haven, CT, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Nov 7, 2024 inspection

• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Approve or reject procedures or specs 21 CFR 211.22(c)
  The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Sep 27, 2022 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not written and followed.
• Acceptance of drug products 21 CFR 211.160(b)(3)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include reliable, meaningful and specific test methods.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Dec 27, 2017 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Written procedures followed 21 CFR 211.186(a)
  Procedures for the preparation of master production and control records are not described in a written procedure and followed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are not written or followed and deficiently written or followed.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in written procedures required by current good manufacturing practice regulations.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store components at all times in a manner to prevent contamination.

May 17, 2016 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Written procedures followed 21 CFR 211.186(a)
  Procedures for the preparation of master production and control records are not described in a written procedure and followed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in written procedures required by current good manufacturing practice regulations.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing , processing , packing and holding of a drug product are not maintained in a good state of repair.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store components at all times in a manner to prevent contamination.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Registered with FDA for: manufacture.