# FDA 483 - Hartley Medical Center Pharmacy, Incorporated - July 08, 2015

Source: https://www.keypedia.com/records/483/hartley-medical-center-pharmacy-incorporated/a8bb8677-40e0-4caa-a51b-54a16f64ea9a

> FDA 483 for Hartley Medical Center Pharmacy, Incorporated on July 08, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hartley Medical Center Pharmacy, Incorporated
- Inspection Date: 2015-07-08
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 was issued to Hartley Medical Center Pharmacy, Incorporated, a producer of sterile drugs located at 113 W Victoria St, Long Beach, CA 90805-2162. The inspection was conducted from June 29, 2015, to July 8, 2015. William A. Stuart, RPh, President, was the recipient of the report.

The inspection revealed six observations:

1.  **Inappropriate Personnel Clothing:** Personnel preparing sterile drug products did not wear goggles, exposing skin around the neck and eyes. Non-sterile gowning materials (scrub pants, scrub jacket, bouffant, face mask) were worn in the aseptic area, and cleanroom pants and jackets were reused throughout the day.
2.  **Deficient Environmental Monitoring:** Personnel monitoring and surface sampling in LAF hoods were not performed daily when final drug products were prepared.
3.  **Inadequate Cleaning and Disinfection:** No sporicidal agent was used in the cleanroom. The Germicidal Solution used for cleaning the aseptic area was not rendered sterile prior to use, and non-sterile materials were used to clean LAF hood surfaces.
4.  **Insufficient Sterilization Process Validation:** Media fills did not adequately simulate the batch process for up to (b)(4) units.
5.  **Lack of Final Product Testing:** Final drug products in pre-

## Related Documents

- [STATE_REFERRAL_LETTER - 2017-03-24](https://www.keypedia.com/records/state_referral_letter/hartley-medical-center-pharmacy-incorporated/2e7d3aef-809f-462a-a857-0b1345d8e3d1)
- [483_RESPONSE - 2017-03-24](https://www.keypedia.com/records/483_response/hartley-medical-center-pharmacy-incorporated/96f306ab-b88c-4579-8d5a-d16dfb20680d)

## Related Officers

- [Caryn Mcnab](https://www.keypedia.com/people/caryn-mcnab/05d5f65d-5ab2-4798-a3a2-2798a82237e1)
- [Laboratory Director](https://www.keypedia.com/people/jennifer-m-gogley/2025f306-80a6-4222-89ac-e4138028292a)
- [Drew M. Love](https://www.keypedia.com/people/drew-m-love/5dd7a6e4-2426-44d2-9e1f-e3a312d0c03c)

Company: https://www.keypedia.com/companies/hartley-medical-center-pharmacy-incorporated/91d66c50-5d07-4596-a29c-d19b3cc0eeca

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b