# FDA 483 - Physician Preferred Medical, LLC - February 19, 2015

Source: https://www.keypedia.com/records/483/physician-preferred-medical-llc/f2dbb32c-cff1-4631-9b8b-8c323c73fce3

> FDA 483 for Physician Preferred Medical, LLC on February 19, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Physician Preferred Medical, LLC
- Inspection Date: 2015-02-19
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 documents observations from an inspection, indicating deficiencies in a drug manufacturing facility. 

**Facility and Operations:** The facility's separate areas and control systems are deficient, failing to prevent contamination or mix-ups. Building construction is not suitable for cleaning, maintenance, and proper operations.

**Quality System and Manufacturing Issues:**
*   **Sterilization and Contamination Control:** Procedures to prevent microbiological contamination of sterile drug products lack validation of the sterilization process. Container closure systems do not adequately protect against deterioration or contamination. Drug product containers and closures were not sterilized and processed to remove pyrogenic properties.
*   **Documentation and Procedures:** Written procedures are not established for equipment cleaning and maintenance, nor for sanitation (lacking responsibility assignments, cleaning schedules, methods, equipment, and materials). Master production and control records are incomplete, and written production and control procedures include batches formulated with less than 100% of the labeled active ingredient.
*   **Investigations:** There is a failure to thoroughly review unexplained discrepancies and out-of-specification results for batches or components, even if distributed.
*   **Personnel:** Personnel clothing is not appropriate for their duties.
*   **Equipment Calibration:** Routine calibration and checking of electronic equipment are not performed according to a written program.

**Laboratory Controls and Testing:**
*   **Specifications and Testing:** Laboratory controls lack scientifically sound specifications and test procedures to assure conformity to identity, strength, quality, and purity

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-10-04](https://www.keypedia.com/records/state_referral_letter/physician-preferred-medical-llc/da6ef07f-971e-47c5-9985-eff8d1dd5416)

## Related Officers

- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/physician-preferred-medical-llc/008c39dd-9657-473b-874f-9d68c5ecefaf

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9