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USFDA FORM 483
USFDA issues Form-483 with 5 observations to Ajanta Pharma's Paithan facilityAjanta Pharma said the US FDA has issued Form-483 with five observations after inspecting its Paithan manufacturing facility in Maharashtra...- Alkem Labs' Chakan facility gets six observations in USFDA inspection, no data integrity issuesAlkem Laboratories announced its subsidiary Enzene Biosciences received a Form 483 from the USFDA. The inspection at the Chakan manufacturi...
- Dr Reddy's gets seven observations from USFDA for Andhra plantDr Reddy's Laboratories faces scrutiny. The USFDA issued a Form 483 after inspecting their Srikakulam facility. The inspection, which occur...
- USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad divisionNatco Pharma announced that its Hyderabad-based pharma division received a Form 483 with seven observations from the USFDA following an ins...
- Glenmark gets five observations from USFDA for Monroe plantGlenmark Pharmaceuticals announced that its Monroe, North Carolina manufacturing plant received a Form 483 with five observations from the ...
- Sun Pharma gets eight observations from USFDA for Halol plantSun Pharma announced that the USFDA issued a Form 483 with eight observations after inspecting its Halol manufacturing plant in Gujarat. Th...
- Dr Reddy's gets 2 observations from USFDA for Telangana API plantDr. Reddy's Laboratories received a Form 483 with two observations following a GMP inspection by the USFDA at its API manufacturing plant (...
- USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma armAurobindo Pharma Ltd announced that the USFDA issued a Form 483 with 11 observations following an inspection of its Aurolife Pharma LLC's R...
- USFDA issues Form 483 with 3 three observations to Gland Pharma's Visakhapatnam unitGland Pharma Ltd's facility at Visakhapatnam received three Form 483 observations from the USFDA after a recent inspection for sterile APIs...
- USFDA issues Form 483 with 1 inspectional observation to Cipla's Kurkumbh unitA routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurk...
- USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unitTorrent Pharmaceuticals said Tuesday that the US health regulator has given them a Form 483 with five procedural comments after inspecting ...
- Gland Pharma's Hyderabad unit gets one observation from USFDA after inspection"This observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA wit...
- USFDA concludes inspection of Unichem Lab's Roha facilityThe inspection was a post-approval inspection and successfully concluded.
- USFDA issues 5 observations to Dr Reddy's plant in HyderabadDr.Reddy's Laboratories was issued a Form 483 which notifies the company's management of objectionable conditions, with 5 observations.
- USFDA completes Biocon's Telangana plant inspectionThe inspection was concluded without any observations and no Form 483 was issued, the company said.
- USFDA completes inspection at Caplin Point Lab's sterile injectable facility in Tamil Nadu"The United States Food and Drug Administration (USFDA) has conducted an inspection at our sterile injectable site (CP-IV) located at Gummu...
- Biocon gets 6 observations from USFDA for Malaysia facilityAs per the US health regulator, observations are made in Form 483 when investigators feel that conditions or practices in the facility are ...
- Received observations from USFDA, responded to all: BioconThe company was responding to reports that the US health regulator has issued observations under Form 483 highlighting issues related to qu...
- Lupin gets three observations from USFDA for Goa plantAs per the USFDA, observations are made in Form 483 when investigators feel that practices in the facility are such that products may becom...
- USFDA made 9 observations post Halol unit inspection: Sun PharmaThe United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Ph...
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