US FDA Issues Establishment Inspection Report, Closing Bioanalytical Facility Inspection With Zero Observations
The US FDA has formally closed its inspection of the company's Bioanalytical Facility at Manikonda, Hyderabad.
- Inspection Period
- 20 July 2026 to 24 July 2026
- Inspection Outcome
- No Observations (Zero 483s)
- Facility Location
- Bioanalytical Facility at Manikonda, Hyderabad
- EIR Release Date
- 30 September 2026
- Regulatory Reference
- 21 CFR 20.64(d)(3)
What happened
The United States Food and Drug Administration (US FDA) inspected the company's Bioanalytical Facility at Manikonda, Hyderabad, from 20 July 2026 to 24 July 2026. The company had disclosed this earlier on 24 July 2026.
The closure
The inspection has been closed with No Observations (Zero 483s). The FDA concluded the inspection under 21 CFR 20.64(d)(3) and released the Establishment Inspection Report (EIR) on 30 September 2026, which the company received the same day.
Why it matters
A Form 483 is issued when FDA investigators note conditions that may be objectionable. Here, none were issued. An EIR is the formal document that signals the inspection is officially closed.
- The facility is a Bioanalytical Facility, used in clinical research work.
- A clean close can support the facility's standing with US-regulated clients.
More numbers
- FDA Form 483 observations issuedNo Observations (Zero 483s)
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