Drug factory · FDA FEI 3005531475

Ophtapharm AG

Riethofstrasse 1, Hettlingen, Switzerland

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.

Feb 28, 2020 inspection

• 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.
• Actual vs. theoretical yields not determined 21 CFR 211.103
  Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.
• Supervisor Training/Education/Experience 21 CFR 211.25(b)
  Individuals responsible for supervising the manufacture of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.

Dec 12, 2017 inspection

• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity 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.
• Aseptic Processing Area 21 CFR 211.42(c)(10)
  Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
• Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
  Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

May 25, 2016 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 and followed.
• 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.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• 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.

Mar 28, 2014 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.
• 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.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: analysis; label; manufacture; pack.