# FDA 483 - Medscript Compounding Pharmacy - July 17, 2019

Source: https://www.globalkeysolutions.net/records/483/medscript-compounding-pharmacy/659079be-65d0-4558-8765-d38917c3737b

> FDA 483 for Medscript Compounding Pharmacy on July 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medscript Compounding Pharmacy
- Inspection Date: 2019-07-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: D&D Pharma, LLC dba MedScript Compounding Pharmacy in Noblesville, IN, was inspected and cited for significant deficiencies in aseptic processing. Observations included inadequate response to microbial contamination in cleanrooms and the use of uncalibrated equipment for critical testing. Additionally, the firm failed to properly disinfect materials entering aseptic areas and did not certify ISO-5 classified areas under dynamic operational conditions.

## Related Documents

- [STATE_REFERRAL_LETTER - 2019-07-08](https://www.globalkeysolutions.net/records/state_referral_letter/medscript-compounding-pharmacy/3f595256-0e02-46c4-bcf0-7a15a0c9bf2c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-y-philopoulos/3ac66ef5-f279-408d-bc21-028421ed1104)
- [Investigator](https://www.globalkeysolutions.net/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)
- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/medscript-compounding-pharmacy/966c6f1d-1466-4144-8e52-68d7b0da1a18

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0