Drug factory · FDA FEI 3006458969

Golden State Medical Supply Inc.

5187 Camino Ruiz, Camarillo, CA, 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.

May 16, 2013 inspection

• Adequate lab facilities not available 21 CFR 211.22(b)
  Adequate lab facilities for testing and approval or rejection of components, drug product containers, closures, packaging materials, in-process materials, and drug products are not available to the quality control unit.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
  Certificates of testing of containers and closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.

Jul 26, 2012 inspection

• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
• 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.

Aug 16, 2011 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.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• No written record of investigation 21 CFR 211.192
  Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.

Feb 2, 2011 inspection

• Label storage access limited to authorized personnel 21 CFR 211.122(d)
  Access to the storage area for labels and labeling materials is not limited to authorized personnel.
• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Sampling and testing plans not followed 21 CFR 211.165(c)
  Written procedures for sampling and testing plans are not followed for each drug product.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not representative of each lot or batch of drug product.
• Individual inventory record 21 CFR 211.184(c)
  Records fail to include an individual inventory record of each drug product container and drug product closure with sufficient information to allow determination of any associated batch or lot of drug product.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy 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.
• 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.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the storage, handling, and approval of components, drug product containers, and closures.

Registered with FDA for: manufacture; relabel; repack.