FDA will also accept the use of Mil

FDA will also accept the use of Military Standard 105E (MIL-STD 105E), May 10, 1989, "Sampling Procedures and Tables for Inspection by Attributes" at an Acceptable Quality Level (AQL) of 6.5, General Inspection Level II.38. Q. If an optical wholesale laboratory or retail laboratory has multiple locations that use the same procedures and equipment, can testing lenses from one location for impact testing cover all locations for compliance with the regulation?A. No. There may be subtle process differences at different locations that can affect the impact resistance of a lens (e.g., wear on a diamond wheel used in surfacing, age of polish, age of coatings, experience of operators). You must test statistically significant samples of each batch of nonprescription lenses and each batch of plastic prescription lenses as well as each glass prescription lens individually. 21 CFR 801.410(d)).39. Q. If finished lenses fail impact testing, even when processed in accordance with the original manufacturer's recommendations, should the wholesale laboratory or retail laboratory notify the original lens manufacturer?