# FDA 483 - Rx Compounding Inc. - August 21, 2014

Source: https://www.keypedia.com/records/483/rx-compounding-inc/3688ca97-01b3-478c-91c5-263812f12733

> FDA 483 for Rx Compounding Inc. on August 21, 2014. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rx Compounding Inc.
- Inspection Date: 2014-08-21
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: During an FDA inspection conducted on August 6, 8, and 21, 2014, several observations were made regarding the firm's sterile ophthalmic drug manufacturing operations.

Observation 1 notes the absence of sterility testing for batches of sterile processed ophthalmic drugs, citing examples such as Vancomycin 25 mg/mL (processed 5/5/2014) and Cyclosporin 1% Suspension (processed 6/19/2014).

Observation 2 highlights deficiencies in environmental monitoring within aseptic processing areas, specifically that environmental monitoring of the (b)(4) does not occur each time a sterile ophthalmic drug is formulated. Examples include Vancomycin 25 mg/mL (processed 7/10/2014) and EDTA 1% (processed 7/18/2014).

Observation 3 indicates that testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to potency limits prior to release. Examples provided are Scopolamine 0.25% O.D. (processed 7/1/2014) and Tobramycin 14 mg/mL O.D. (processed 7/23/2014).

Observation 4 states that separate or defined areas to prevent contamination or mix-ups are deficient regarding aseptic processing operations, specifically that the (b)(

## Related Documents

- [483 - 2016-08-19](https://www.keypedia.com/records/483/rx-compounding-inc/f2e9c743-92e1-4f53-9883-b88b15ddb379)
- [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

- [Investigator ](https://www.keypedia.com/people/larry-k-austin/174b94ad-67d6-4610-8a32-eb5cffbfc37d)

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