Drug factory · FDA FEI 3010167787
RX Pharma-Pack, Inc.
Hauppauge, New York, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Oct 10, 2014.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2013: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 10, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Sep 27, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 10, 2014 inspection
- 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 packaging of the drug product. - Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Correct labels during finishing operations 21 CFR 211.134(a)
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the holding of a drug product are not maintained in a good state of repair. - 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 27, 2013 inspection
- 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.