Drug factory · FDA FEI 2911183

Linde Gas & Equipment Inc.

1930 Loveridge Rd, Pittsburg, 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.

Jul 15, 2010 inspection

• 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 established.
• Labeling and packaging improperly approved/released 21 CFR 211.122(b)
  Labeling and packaging materials not meeting the appropriate written specifications were released for use.
• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• 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.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures are not followed.
• Review of problem drugs 21 CFR 211.180(e)(2)
  The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of complaint, recall, returned drug product, salvaged drug product, and investigation records for each drug product.
• 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.
• 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
• 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.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store drug product containers at all times in a manner to prevent contamination.

Registered with FDA for: manufacture.