Drug factory · FDA FEI 1000125370

Paklab

14570 Monte Vista Ave, Chino, 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 29, 2025 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not documented at the time of performance.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not established.
• Stability sample storage conditions described 21 CFR 211.166(a)(2)
  The written stability program for drug products does not describe the storage conditions for samples retained for testing.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include meaningful test methods.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to approve and reject all components and drug products.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.

Nov 17, 2023 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.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established specifications and laboratory control mechanisms are not followed and documented at the time of performance.
• 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.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications 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.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Mfg / Processing Operations Area 21 CFR 211.42(c)(5)
  Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
• 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.
• 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.

Mar 17, 2023 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.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
• 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 cleaning and maintenance.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
• Component identification test 21 CFR 211.84(d)(2)
  Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

Dec 22, 2015 inspection

• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written test procedures and laboratory mechanisms are not justified.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of specifications, test procedures, and laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.

Registered with FDA for: manufacture.