# FDA 483 - Pentec Health - April 01, 2013

Source: https://www.keypedia.com/records/483/pentec-health/ae3da0a9-dbca-4f31-8f11-3731e3cb1984

> FDA 483 for Pentec Health on April 01, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pentec Health
- Inspection Date: 2013-04-01
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: The FDA Form 483 details numerous deficiencies at a facility processing injectable drug products, observed between March 18-19, 2013.

**Key Violations and Observations:**

*   **Sterilization and Aseptic Processing:** Procedures for preventing microbiological contamination lacked adequate sterilization process validation. Aseptic techniques were deficient, with personnel exhibiting exposed skin (face, neck, forearms) inside ISO 5 Laminar Air Flow (LAF) hoods, leaning over open containers, and having exposed facial hair. Disinfection protocols were not followed for reintroducing items into hoods or for initial equipment placement.
*   **Facility and Equipment Maintenance:** ISO 5 LAF hoods showed whitish residues, dark stains on HEPA filters, and dark splatters on light fixtures. Equipment obstructed airflow. Non-sterile powder dispensing occurred outside ISO 5 hoods. IV bags were stored improperly, with ports exposed.
*   **Validation and Testing:** No validation records for sterilization steps or media fill studies simulating actual production were available. Sterility unit procedures were incomplete. Sterility and endotoxin testing SOPs were unsigned/unapproved. Finished products were not incubated at correct temperatures.
*   **Quality Control and Stability:** No written stability program or data existed for various drug products (Proplete IV, Bupivacaine, Morphine, Hydromorphone stock solutions) to support assigned beyond-use dates.
*   **Investigations:** Out-of-

## Related Documents

- [WARNING_LETTER - 2013-04-01](https://www.keypedia.com/records/warning_letter/pentec-health/b2cb6538-8a4b-4acc-b0f0-9066032d1d12)
- [145 - 2017-05-05](https://www.keypedia.com/records/145/pentec-health/84d7bc58-cc65-483c-a7cf-3929b54ec6ac)
- [STATE_REFERRAL_LETTER - 2016-08-08](https://www.keypedia.com/records/state_referral_letter/pentec-health/2ad5ff13-2038-4cd1-b20f-544954ca3c0a)
- [145 - 2018-03-12](https://www.keypedia.com/records/145/pentec-health/a462dc66-e4f6-4392-a4bb-63605615ceba)
- [145 - 2018-08-31](https://www.keypedia.com/records/145/pentec-health/b1d00c48-e979-4510-bc76-a398a68d7ab6)

## Related Officers

- [Senior Mutual Recognition Program Officer](https://www.keypedia.com/people/julianne-c-mccullough/87873501-94b3-4eee-8d67-5d241cb9bbf9)
- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

Company: https://www.keypedia.com/companies/pentec-health/685ee832-8b77-4209-b00a-35aa6879f13a

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8