Drug factory · FDA FEI 1641527

Physicians Total Care, Inc.

Tulsa, Oklahoma, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

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 24, 2012 inspection

• Written procedures followed 21 CFR 211.186(a)
  Procedures for the preparation of master production and control records are not followed.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into the failure of a batch or any of its components to meet specifications.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not 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.
• Penicillin processing area not kept separate 21 CFR 211.42(d)
  The operations relating to the packing of penicillin are not performed in facilities separate from those used for other drug products for human use.
• 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.

Sep 15, 2010 inspection

• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals in accordance with an established written program.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
• Signature and checking of records -- 2 persons 21 CFR 211.186(a)
  The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the packing of a drug product lack the training required to perform their assigned functions.