# FDA 483 - Rx Compounding Inc. - August 19, 2016

Source: https://www.keypedia.com/records/483/rx-compounding-inc/f2e9c743-92e1-4f53-9883-b88b15ddb379

> FDA 483 for Rx Compounding Inc. on August 19, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rx Compounding Inc.
- Inspection Date: 2016-08-19
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: On August 8, 9, 10, 11, 12, 16, and 19, 2016, the FDA inspected Rx Compounding Inc., a producer of sterile drug products located at 1101 E. 86th St., Indianapolis, IN 46240. The inspection identified eight observations.

Observation 1 noted inadequate disinfection of equipment and materials entering aseptic processing areas, specifically during Vancomycin and Tobramycin compounding, where sterile spray did not contact all surfaces. Observation 2 cited personnel blocking first-pass air by passing hands over open sterile ophthalmic bottles during aseptic compounding. Observation 3 detailed the use of non-sterile, ill-fitting nitrile gloves by personnel in aseptic processing, which were not sanitized until after exposure to the ISO 5 environment.

Observation 4 indicated the ISO 5 classified area was within a non-classified room, with an uncertified HEPA filter in the anteroom partially covered. Observation 5 stated that chemical sanitizing agents were not used in the cleanrooms, with only a non-chemical method used for the curtained anteroom. Observation 6 found environmental monitoring was not representative of aseptic conditions, citing desiccated and expired agar plates for air testing and test media lacking sanitant neutralizing ingredients for fingertip monitoring.

Observation 7 reported that the certification of the ISO 5 area did not include dynamic conditions for unidirectional airflow studies.

## Related Documents

- [483 - 2014-08-21](https://www.keypedia.com/records/483/rx-compounding-inc/3688ca97-01b3-478c-91c5-263812f12733)
- [483_RESPONSE - 2016-08-19](https://www.keypedia.com/records/483_response/rx-compounding-inc/b86a0b93-c45a-4cfb-bfb8-d34ec884e918)
- [483 - 2016-08-19](https://www.keypedia.com/records/483/rx-compounding-inc/0dba26a4-bde5-4235-be85-c48680ffc8e1)

## Related Officers

- [Robert M. Barbosa](https://www.keypedia.com/people/robert-m-barbosa/41672e72-4ddd-4093-8069-6e49f0c8a873)

Company: https://www.keypedia.com/companies/rx-compounding-inc/7455ac76-39f4-4a99-8519-b2b93516fdb6

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03