Drug factory · FDA FEI 3002807173

Hikma Farmaceutica (portugal), S.a

ESTRADA RIO DA MO, 8/8A/8B, Terrugem Sintra, Portugal

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.

Apr 21, 2023 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Incoming lots - conformance to written specs- 21 CFR 211.160(b)(1)
  Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of drug products used in the manufacture, processing, packing, or holding of drug products.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not 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.
• Written calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.

Jun 19, 2015 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

Mar 28, 2014 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.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written specifications are not justified.
• Microbiological testing 21 CFR 211.165(b)
  Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• Testing and standardization of standards et. al. 21 CFR 211.194(c)
  Laboratory records do not include complete records of any testing and standardization of laboratory reference standards.

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